Computer-Assisted Cancer Risk Behavior Counseling

Hypertension Clinical Trial

Official title:

Computer-Assisted Cancer Risk Behavior Counseling

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00242645
• Other study ID #: 04F.244
• Secondary ID: K07-CA91976-0
• Status: Terminated
• Phase: Phase 1
• First received: October 19, 2005
• Last updated: August 24, 2010
• Start date: June 2004
• Est. completion date: June 2007

Study information

• Verified date: August 2010
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To test whether or not giving patients information before their doctor visits changes the care they receive and what type of information is best to give before the doctor visit.

Description:

Patients are randomized into one of three groups. Before a single visit with diabetes care provider, the patient is called to answer interview questions about their health, diabetic care and behavior habits. After a patient visits with their doctor, they are called again to answer question about the visit they just had. If a patient is place into group A or B, based on their answers to the questions they are mailed a printed report before their doctor visit. The report will indicate how things are going the patient's diabetic care and recommended questions to ask his/her health care provided about diabetes. Group A feedback report will emphasize the risks from diabetes and the feedback reports for Group B will emphasize things to do to protect oneself from problems from having diabetes. Participants randomized to Group C will only receive printed reports after a doctors visit. No extra visit will be scheduled with the participants doctor, no travel is required, no blood tests are required and ther doctor will not be involved in the study unless the study participant chooses to discuss it with his/her doctor.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18 years of age or older;

• Has type 2 (adult-onset) diabetes;

• Developed diabetes after the age of 21;

• Has a scheduled doctor visit about diabetes in the next few months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Hypertension

Intervention

Behavioral:
• Health Information

• Preventive Services

• Computer tailored information

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To test the effect of receiving computer tailored information about diabetes care before doctor visits and the differential effect of varying types of information
Secondary	Patient exit interviews after doctor visits about what happened during the visits, such as what was discussed, what tests and consults were ordered and what medications were added or changed.